Massager, Therapeutic, Electric

FDA product code ISA · 100 cleared devices

Class 1 Physical Medicine

Regulation: 21 CFR 890.5660
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-01-13 – 2025-02-06

ISA 2025-02-06

VMAT PRO

Applicant Termosalud

K number K243488

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ISA 2024-06-05

ShockPhysio Mobile (model SW3200 Basic)

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K240358

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ISA 2023-04-14

BTL-094

Applicant BTL Industries, Inc.

K number K221865

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ISA 2023-01-27

Omnispec ED1000

Applicant Medispec, Ltd.

K number K210166

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ISA 2022-10-12

OW100S (model OW100S-US)

Applicant Tissue Regeneration Technologies, LLC Dba AS Softwave Trt

K number K213120

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ISA 2022-07-11

DolorClast Radial

Applicant E.M.S Electro Medical Systems S.A

K number K220538

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ISA 2021-05-05

OrthoGold 100

Applicant Tissue Regeneration Technologies, LLC

K number K210451

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ISA 2018-12-21

OrthoGold 100

Applicant Tissue Regeneration Technologies

K number K182682

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ISA 2018-04-13

D-Actor 200 Vibration Massage System

Applicant Storz Medical AG

K number K173692

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ISA 2006-11-06

CELLU M6 KEYMODULE I

Applicant Lpg One, Inc.

K number K053225

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ISA 2004-01-22

CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM

Applicant Cynosure, Inc.

K number K030876

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ISA 2001-08-30

JET THERAPY

Applicant Jet Therapy

K number K002908

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ISA 2000-01-18

LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR

Applicant Lpg USA, Inc.

K number K990445

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ISA 1995-09-29

SPIN ROLLERE

Applicant Kinsei Shiatsu, Inc.

K number K952990

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ISA 1995-08-14

BODYFLEX MASSAGER

Applicant Truro'S Ent.

K number K952041

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ISA 1995-08-02

RELAXU-1

Applicant Kinsei Shiatsu, Inc.

K number K950411

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ISA 1995-04-05

AVON MASSAGING HAIRBRUSH

Applicant Siegel,Mandell & Davidson,P.C.

K number K950931

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ISA 1995-03-07

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES

Applicant Ultrassage, Inc.

K number K950655

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ISA 1995-02-14

RELAXY-THE WONDER HAND

Applicant Kinsei Shiatsu, Inc.

K number K950322

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ISA 1995-02-14

SHAPE UP MOMI ROLLER

Applicant Kinsei Shiatsu, Inc.

K number K950321

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ISA 1995-02-14

RELAXY-WONDER KNOCK

Applicant Kinsei Shiatsu, Inc.

K number K950320

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ISA 1995-02-14

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000

Applicant Kolvin Industries , Ltd.

K number K944885

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ISA 1995-02-14

DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B

Applicant Kolvin Industries , Ltd.

K number K944884

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ISA 1995-02-14

MASSAGER

Applicant North American Technical Services Corp.

K number K944730

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ISA 1995-01-18

AGILANCE-GOLDEN SPOONS

Applicant Oismuller & Partner Keg

K number K936178

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ISA 1994-12-13

FAMILY FITNESS SHIATSU MASSAGER

Applicant Conair Corp.

K number K944637

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ISA 1994-12-08

STIMU-TAP

Applicant Wahl Clipper Corp.

K number K944024

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ISA 1994-09-29

FAMILY FITNESS SHIATSU MASSAGER

Applicant Conair Corp.

K number K943092

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ISA 1994-07-26

BODY FLEX

Applicant Conair Corp.

K number K942950

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ISA 1994-06-22

SHIATSU MASSAGER

Applicant Westminster International Co., Inc.

K number K942218

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ISA 1994-06-22

PRO-SHIATSU PORTABLE MASSAGER

Applicant Westminster International Co., Inc.

K number K940621

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ISA 1994-06-09

BODY SYSTEM

Applicant Conair Corp.

K number K942223

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ISA 1994-06-09

WAHL DOUBLE COMFORT MASSAGER

Applicant Wahl Clipper Corp.

K number K941594

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ISA 1994-06-09

WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA

Applicant Wahl Clipper Corp.

K number K940683

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ISA 1994-04-21

MODEL 777 THERAPEUTIC MASSAGER

Applicant Voyager Medical Corp.

K number K940543

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ISA 1994-04-21

BODY RECHARGER

Applicant Conair Corp.

K number K940369

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ISA 1994-03-30

AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER

Applicant Pollenex Corp.

K number K925907

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ISA 1994-03-28

FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER

Applicant Fairform Mfg., Co., Ltd.

K number K931636

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ISA 1994-03-04

OMRON MASSAGER MODEL HM-102

Applicant Omron Healthcare, Inc.

K number K935581

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ISA 1994-03-04

OMBRON TWIN-HEAD MASSAGER MODEL HM-101

Applicant Omron Healthcare, Inc.

K number K935462

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ISA 1994-03-04

OMRON MASSAGER MODEL HM-45

Applicant Omron Healthcare, Inc.

K number K935459

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ISA 1994-03-04

BODY RELAXER

Applicant Conair Corp.

K number K926339

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ISA 1994-02-25

INFRADERM; TOUCH 'N TONE PLUS

Applicant Conair Corp.

K number K911727

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ISA 1994-02-17

WINDMERE WAND MASSAGER

Applicant Windmere Corp.

K number K932904

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ISA 1993-10-18

WINDMERE PRELUDE III

Applicant Windmere Corp.

K number K924237

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ISA 1993-10-12

BODY SOOTHER

Applicant Conair Corp.

K number K924518

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ISA 1993-09-30

BODY TRAINER

Applicant Conair Corp.

K number K924520

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ISA 1993-06-29

HANDY VIBRO BELT

Applicant Cosmesearch, Inc.

K number K925036

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ISA 1993-06-24

BODY-MATE MASSAGER

Applicant American Therapy Products

K number K923541

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ISA 1993-03-31

SONACARE SOUND MASSAGER

Applicant Honor Trading, Ltd.

K number K921000

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ISA 1992-04-29

AUQASOOTHE/AQUA MED

Applicant Aquasoothe

K number K915729

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ISA 1992-04-02

AQUA MED

Applicant Aqua Massage Intl., Inc.

K number K914943

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ISA 1992-02-11

PERSONAL BODY MASSAGER, MODELS 1605 & 1606

Applicant Raymond Industrial, Ltd.

K number K912822

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ISA 1991-10-07

VIBRATOUCH II CORDLESS WAND MASSAGER

Applicant Conair Corp.

K number K912383

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ISA 1991-09-12

CORDLESS ELECTRIC MASSAGER EV315

Applicant Matsushita Electric Co.

K number K912634

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ISA 1991-04-01

GOOD VIBRATIONS TUBE MASSAGER

Applicant Dual Voltage, Inc.

K number K910519

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ISA 1990-11-27

CARESS MASSAGER

Applicant Kendex Corp.

K number K904915

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ISA 1990-11-26

MUSCLE MASSAGER

Applicant Uri Halfon and Gabriel Hertzberg

K number K903617

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ISA 1990-10-11

QI-GONG MACHINE THERAPEUTIC MASSAGER

Applicant China Healthways Institute

K number K904242

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ISA 1990-06-06

PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE

Applicant Component Equipment Mfg., Inc.

K number K901796

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ISA 1990-03-02

CONSTI-SSAGE VIBRATOR/MASSAGE

Applicant Bio-Tech Co.

K number K900674

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ISA 1989-05-31

OMRON TRAVEL MASSAGER, MODEL HM-01

Applicant Omron Electronics, Inc.

K number K893029

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ISA 1989-05-26

COMFORTRAC, CT90 & CT100 BI-PHASICS

Applicant Comfortrac Systems

K number K892669

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ISA 1989-04-25

PHASER (SINGLE LINEAR MECHANICAL MASSAGE)

Applicant Monad Corp.

K number K891871

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ISA 1989-04-10

PM830 ELECTRIC MASSAGER

Applicant Back IN Action, Inc.

K number K891394

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ISA 1989-03-14

VITALON MATRESS MASSAGE MODEL M-MX

Applicant Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.

K number K890923

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ISA 1989-02-22

VITALON CHAIR MASSAGER MODEL V-CHR2

Applicant Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.

K number K890643

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ISA 1988-08-23

MASSAGE MACHINE (CAT. EM-01 ULE 111756)

Applicant Emrad, Ltd.

K number K883064

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ISA 1988-02-11

PULSOR, THERAPEUTIC VIBRATOR

Applicant Gmg Enterprises, Inc.

K number K874716

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ISA 1988-01-22

MODIFIED STRESS MACHINE

Applicant S.J.F., Inc.

K number K873819

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ISA 1988-01-20

VITALON MASSAGER

Applicant Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.

K number K874843

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ISA 1987-12-10

HOT ROD THERMAL MASSAGE ROLLER

Applicant American Progressive Products Corp.

K number K873794

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ISA 1987-07-31

BIRDIE BRACKET

Applicant William W. Wilkerson & Gregory A. Knutson

K number K872028

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ISA 1987-04-06

VIBRACARE

Applicant General Physiotherapy, Inc.

K number K870939

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ISA 1986-11-03

HITACHI HAND HELD MASSAGER A/C POWERED

Applicant Hitachi Sales Corporation of America

K number K864088

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ISA 1986-09-19

VIBROFLEX

Applicant Stoffregen & Co., Inc.

K number K863197

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ISA 1986-09-15

FACIAL MASSAGER, BATTERY POWERED

Applicant General Physiotherapy, Inc.

K number K863383

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ISA 1986-06-17

WM10, WM20, WM30 POWER MASSAGER

Applicant Associated Mills, Inc.

K number K862041

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ISA 1986-05-27

THERACUSHION MODEL 1000

Applicant General Physiotherapy, Inc.

K number K861834

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ISA 1986-01-03

THERACUSHION

Applicant General Physiotherapy, Inc.

K number K853710

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ISA 1985-11-05

MULTIPLE

Applicant Sun Air, Inc.

K number K853297

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ISA 1985-09-05

FLEXIMATIC MASSAGER

Applicant General Physiotherapy, Inc.

K number K852944

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ISA 1985-06-25

G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S

Applicant Physio Technology, Inc.

K number K850851

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ISA 1985-05-14

OSTER MASSAGE WAND STICK MASSAGER 295-07

Applicant Daito Electric Machine Industries Company, Ltd.

K number K850771

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ISA 1984-08-01

VACOMED 4

Applicant Robert Bosch Corp.

K number K842802

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ISA 1984-01-30

HAYDAY IRRIT-EASER WAND

Applicant Hayday Irrit-Easer

K number K840035

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ISA 1983-11-29

MASSATOR-PEDIO

Applicant Trileen, Inc.

K number K833840

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ISA 1983-11-07

BACK MASSAGER B-400 ADJUSTABLE

Applicant Pollenex Associated Mills, Inc.

K number K832913

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ISA 1983-10-14

SENSORY ROLLER MASSAGER

Applicant Maddak, Inc.

K number K833090

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ISA 1983-07-12

STRESS MACHINE

Applicant Dr. William F. Curran

K number K831699

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ISA 1983-06-02

ARUBI FLATTER & ARUBI FLATTER-S

Applicant Kc Export Management Co.

K number K831206

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ISA 1983-02-15

HIPUSH HANDHELD MASSAGER

Applicant New Age Corp.

K number K823927

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ISA 1982-08-31

TRIMMORE ELECTION BEAUTIFIER

Applicant Rn Int'L, Inc.

K number K821109

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ISA 1981-07-31

SOFT & STROKE

Applicant Phoenix Intl. Marketing, Inc.

K number K811782

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ISA 1981-07-20

NORELCO MASSAGER PLUS HEAT BELT

Applicant North American Philips Corp.

K number K811891

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ISA 1981-03-04

MAGIC CUSHION MASSAGER

Applicant Fred Sammons, Inc.

K number K810447

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ISA 1981-02-23

PERCUSS-O-FLEX FOOT & HAND MASSAGER

Applicant Modern Reflexology, Inc.

K number K810354

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ISA 1980-08-20

LEBODY BY WATER PIK

Applicant Teledyne, Inc.

K number K801593

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ISA 1978-05-03

TISSUE PULSATOR

Applicant Pulsator Corp.

K number K780683

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ISA 1977-01-13

PROPIOCEPTOR MASSAGER

Applicant Cellers Research, Inc.

K number K760616

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